Endocardial lead cutting apparatus

ABSTRACT

In some embodiments, without limitation, the invention comprises an apparatus for cutting an endocardial lead within a patient. The apparatus comprises a generally flexible tubular member having a proximal end and distal end. At least one blade or cutting surface is affixed to the distal end of the tubular member. The apparatus optionally includes an adjustment mechanism adapted to adjust the blade or cutting surface between an extended position and a retracted position. The blade or cutting surface engages the endocardial lead to cut the lead. Various embodiments include a v-shaped groove defining the cutting surfaces. Other embodiments may comprise a rotatable blade of an inner shaft rotating within the tubular member and cutting the lead received within the v-shaped groove, and blades or cutting surfaces functioning like guillotines or scissors retracting into a distal end of the tubular member.

FIELD OF THE INVENTION

This invention relates generally to an endocardial lean cuttingapparatus and, more particularly, to an apparatus including at least oneblade or cutting surface for cutting endocardial leads within a patient.

BACKGROUND OF THE INVENTION

In the past, various types of endocardial leads and electrodes have beenintroduced into different chambers of a patient's heart, including theright ventrical, right atrial appendage, and atrium as well as thecoronary sinus. These flexible leads usually are composed of aninsulator sleeve that contains an implanted helical coil conductor thatis attached to an electrode tip. This electrode is placed in contactwith myocardial tissue by passage through a venous access, often thesubclavian vein or one of its tributories, which leads, to theendocardial surface of the heart chambers. The tip with the electrodecontact is held in place by trabeculations of myocardial tissue.

The tips of many available leads include flexible tines, wedges, orfinger-like like projections which extend radially outward and usuallyare molded from and integral with the insulating sheath of the lead.These tines or protrusions allow surrounding growth of tissue inchronically implanted leads to fix the electrode tip in position in theheart and prevent dislodgement of the tip during the life of the lead.In “acute placement” of the electrode or lead tip, a blood clot formsabout the flanges or tines (due to enzymes released as a result ofirritation of the trabeculations myocardial tissue by the presence ofthe electrode tip) until scar tissue eventually forms, usually in threeto six months. The tines or wedges or finger-like projections allowbetter containment by the myocardial trabeculations of muscle tissue andprevent early dislodgement of the lead tip.

Although the state of the art in implemented pulse generator orpacemaker technology and endocardial lead technology has advancedconsiderably, endocardial leads nevertheless occasionally fail, due to avariety of reasons, including breakage of a lead, insulation breaks,breakage of the inner helical coil conductor and an increase inelectrode resistance. Furthermore, in some instances, it may bedesirable to electronically stimulate different portions of the heartthan are presently being stimulated with the leads already implanted.There are a considerable number of patients who have one or more, andsometimes as many as four or five unused leads in their veins and heart.

Although it obviously would be desirable to easily remove such unusedleads, in the past surgeons usually have avoided attempts to removeinoperative leads because the risk of removing them exceeded the risk ofleaving them in. The risks of leaving unused myocardial leads in theheart and venous path include increased likelihood that an old lead mayfacilitate infection, which in turn may necessitate removal of the leadto prevent continued bacteremia and abcess formation. Furthermore, thereis an increased likelihood of the formation of blood clots in the atrialchamber about entangled leads. Such clots may embolize to the lung andproduce severe complications and even fatality. Furthermore, thepresence of unused leads in the venous pathway and inside the heart cancause considerable difficulty in the positioning and attachment of newendocardial leads in the heart.

Removal of an inoperative lead sometimes can be accomplished by applyingtraction and rotation to the outer free end of the lead, for example, ifdone prior to fixation of the lead tip in the trabeculations ofmyocardial tissue by scar tissue formation or large clot development.Even then, it is possible that a clot has formed so the removal of theleads causes various sized emboli to pass to the lungs, producing severecomplications.

In cases where the lead tip has become attached by scar tissue to themyocardial wall, removal of the lead always has presented major problemsand risks. Porous lead tips that are sometimes used may have an ingrowthof scar tissue attaching them to the myocardial wall. Sufficienttraction on such leads in a removal attempt could cause disruption ofthe myocardial wall prior to release of the embedded lead tip, The tinesor flanges of other types of leads that are not tightly scarred to themyocardial wall present similar risks. Even if screw-in tip electrodesare used, wherein the tips theoretically can be unscrewed from themyocardial wall, unscrewing of such tips may be prevented by a channelof scar tissue and endothelium that surrounds the outer surface of thelead along, the venous pathway. Such “channel scar” tissue preventswithdrawal because of tight encasement of the lead. Continual strongpulling or twisting of the outer free end of the lead could causerupture of the atrial wall or the ventricular wall if there is suchtight circumferential encasement of adherent channel scar tissue in thevenous path. Such tight encasement by scar tissue in the venous pathwayand in the trabeculations of the myocardial wall typically occurs withinsix months to a year of the initial placement of the lead.

The risks of removing the lead by such traction and rotation of the leadare so high that, if it becomes imperative that the lead be removed (asin the case of infection), most surgeons have elected to open thepatient's chest and surgically remove the load rather than attemptremoval by applying traction and rotation thereto.

Clearly, there is a need for an apparatus for extracting endocardialleads from a patient's heart with minimal risk to the patient.

SUMMARY OF THE INVENTION

To address these and other drawbacks, in some embodiments, withoutlimitation, the present invention comprises an apparatus for cutting thelead as near as possible to an endocardial lead's embedded electrode.

Specifically, the present invention comprises an apparatus having agenerally flexible tubular member having a proximal end and distal end.At least one blade or cutting surface is affixed to the distal end ofthe tubular member. In some embodiments, the apparatus includes anadjustment mechanism adapted to adjust the blade or cutting surfacebetween an extended position and a retracted position.

Other aspects of the invention will be apparent to those skilled in theart after reviewing the drawings and the detailed description below.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described, by way of example, withreference to the accompanying drawings, in which:

FIG. 1 illustrates a perspective view of an endocardial lead cuttingapparatus of a first embodiment of the present invention;

FIG. 2 illustrates a perspective view of an endocardial lead cuttingapparatus of a second embodiment of the present invention;

FIG. 3 illustrates an enlarged perspective view of a distal end of anouter tubular member of the second embodiment of the present invention;

FIG. 4 illustrates to 3 enlarged perspective view of a distal end of aninner shaft of the second embodiment of the present invention;

FIG. 5A-5C illustrate end views of the endocardial lead cuttingapparatus of the second embodiment of the present invention having theinner shaft rotating to cut the lead;

FIG. 6 illustrates a cross-sectional vie of an endocardial lead cuttingapparatus of a third embodiment of the present invention;

FIG. 7 illustrates an enlarged cross-sectional view of a distal end ofthe endocardial lead cutting apparatus of the third embodiment of thepresent invention;

FIG. 8 illustrates a perspective view of an endocardial lead cuttingapparatus of a fourth embodiment of the present invention;

FIG. 9 illustrates a perspective view of an endocardial lead cuttingapparatus of a fifth embodiment of the present invention;

FIG. 10 illustrates a perspective view of an endocardial lead cuttingapparatus of a sixth embodiment of the present invention; and

FIGS. 11A-11C illustrate enlarged perspective views of the distal end ofthe endocardial lead cutting apparatus of the sixth embodiment.

DETAILED DESCRIPTION

Referring generally to FIGS. 1-11 and without limiting the scope of theembodiments of the invention, various embodiments of an apparatus aregenerally referred to at 10 for cutting an endocardial lead 100.

Referring to FIG. 1, the apparatus 10 of a first embodiment includes ashaft 12 having a proximal end 14 and a distal tip 16. The shaft 12 isgenerally flexible to facilitate movement of the apparatus 10 within thepatient. The proximal end 14 of the shaft 12 includes a handle 18 whilethe distal tip 16 includes at least one cutting surface 20.

The at least one cutting surface 20 is defined by a groove 22 at thedistal tip 16. The groove 22 is illustrated as generally v-shaped.Accordingly, as illustrated, the v-shaped groove 22 defines two cuttingsurfaces 20. Further, the cutting surfaces 20 are comprised of agenerally hardened material, such as carbide and the like. Whileillustrated as a v-shaped groove 22, other configurations, such asu-shaped, c-shaped and the like are contemplated by the presentinvention.

Optionally, a shroud (not shown) is positioned about the shaft 12 suchthat a distal end of the shroud extends outwardly of the distal tip 16of the shaft 12. The shroud is made of a generally pliable material toprevent damage to tissue of the patient prior to use of the apparatus10.

Further, as an additional optional feature, the apparatus 10 may includea device (not shown) to provide an additional form of energy to cut theendocardial lead. By way of example, the device may be a lasergenerating device, an ultrasonic device, a vibration device and thelike. The exemplary devices would apply radiation, ultrasonic waves orvibrations, respectively, to the lead 100 to assist in cutting the lead100. In the example of as laser generating device, an optical fiber (notshown) would be disposed within the shaft 12 to transmit radiation fromthe proximal end 14 to the distal tip 16.

In operation, the first embodiment of apparatus 10 of FIG. 1 is insertedwithin a patient's heart (not shown) and the lead 100 (shown in phantom)is received within the groove 23 at the distal tip 16. When positionedto receive the lead 100 the pliable shroud is urged away from the distaltip 16 to expose the groove 22 and cutting surfaces 20. Linear androtation motion is applied by way of the handle 18 to the shaft 12. Thecutting surfaces 20 of the groove 22 then engages the lead. Asadditional pressure is applied the cutting surfaces 20 cut the lead andthe apparatus 10 is removed from the patient. Optionally, when the lead100 is received in the groove 22 the additional forms of energy such asradiation, ultrasound or vibration is applied to the lead to assist incutting the lead 100.

A second embodiment of the apparatus 10 is shown in FIGS. 2-5. Thesecond embodiment includes an outer tubular member 212 having a proximalend 214 and a distal end 216. The outer tubular member 212 is generallyflexible to facilitate movement of the apparatus 10 within the patient.The distal end 216 includes a groove 220 for receiving the lead 100. Asillustrated, the groove 220 is generally v-shaped for receiving, thelead 100; however, other configurations are also contemplated by thepresent invention.

An inner shaft 222 is received within the outer tubular member 212. Theinner shaft 222 includes a proximal end 224 and a distal end 226.Further, the inner shaft 222 is generally flexible and includes a handle228 disposed at the proximal end 224. Positioned at the distal end 226of the inner shaft is a blade 230. The blade 230 and the inner shaft 222is made from a generally hardened material, such as carbide and thelike, and rotates within the outer tubular member 212 to cut the lead100 received within the groove 220 of the outer tubular member 212. Theinner shaft 222 and blade 230 are rotatable in either direction.

Further, as described with respect to the first embodiment of FIG. 1,the apparatus 10 may include a shroud (not shown). The shroud ispositioned about the outer tubular member 212 such that a distal end ofthe shroud extends outwardly of the distal end 216 of the outer tubularmember 212. The shroud is made of a generally pliable material toprevent damage to tissue of the patient prior to use of the apparatus10.

In operation, the second embodiment of apparatus 10 of FIGS. 2-5 isinserted within a patient's heart and the lead 100 is received withinthe groove 220 at the distal end. 216 of the outer tubular member 212.When receiving, the lead 100 within the groove 220, the inner shaft 222and blade 230 are in a home position such that the blade 230 isgenerally offset from the groove 220. A positioning mechanism (notshown) may be included to bias the inner shaft 222 and blade 230 to thehome position within the outer tubular member 212. When positioned toreceive the lead 100 the pliable shroud is urged away from the distalend 216 to expose the groove 220 and blade 230. When the distal end 216of the outer tubular member 212 is positioned as close as possible tothe embedded electrode of the lead, the handle 228 of the inner shaft222 is rotated and the blade 230 contacts the lead. Further rotation ofthe inner shaft 222 and the blade 230 cuts the lead 100. The apparatus10 is then removed from the patient.

Now referring to FIGS. 6-7, a third embodiment of the apparatus 10 ofthe present invention is illustrated. The apparatus 10 includes atubular member 312 having a proximal end 314 and a distal end 316. Thetubular member 312 is generally flexible and preferably made from aplastic or elastomeric material.

A housing 318 is generally disposed at the distal end 316 of the tubularmember 312. The housing 318 includes an opening 320 for receiving theendocardial lead 100. Preferably, the housing 318 is made of stainlesssteel and is joined to the distal end 316 of the tubular member 312 byuse of an adhesive. However, any technique for joining the housing 318and the distal end 316 of the tubular member 312 is contemplated by thepresent invention.

Disposed within the housing 318 are a blade 322 and a plunger 324. Theblade 322 is received within the plunger 324, preferably bypress-fitting the blade 322 within the plunger 324. The blade 322 ismade of carbide and moveable between an extended position and aretracted position. When in the extended position, the blade 322 isreceived within the opening 320 of the housing 318 to cut the lead 100received therein.

The tubular member 312 includes a handle 326. The handle 326 is joinedto the proximal end 314 of the tubular member 312 by adhesive and thelike. Alternately, the handle 326 is press fit within the proximal end314 of the tubular member 312. The handle 326 is utilized to actuate theblade 322 between the extended and retracted positions.

Further, the apparatus 10 of the third embodiment includes an adjustmentmechanism generally referred to at 328. The adjustment mechanism 328moves the blade 322 between the extended and retracted positions.Specifically, the adjustment mechanism 328 may comprise a screw 330. Afirst end 332 of the screw 330 is received at a proximal end 334 of theplunger 324. A second end 336 of the screw 330 extends through aretainer 338. The retainer 338 is generally disposed at a proximal end340 of the housing 318.

The adjustment mechanism 328 further includes a universal joint 342 anddrive wire 344. The universal joint 342 is disposed at the second end336 of the screw 330. The universal joint 342 is also attached to thedrive wire 344. The drive wire 344 extends through the tubular member312 and attaches to the handle 326. Further, the handle 326 includes aknob 346. The knob 346 rotates to adjust the blade 322 between theextended and retracted positions.

In operation, the apparatus 10 of the third embodiment of the presentinvention of FIGS. 6-7 is inserted within a patient's heart and receivesthe lead 100 within the opening 320 of the housing 318. The adjustmentmechanism 328 is actuated by rotating the knob 346. Rotational motionfrom the knob 346 is transferred through the drive wire 344 anduniversal joint 342 to rotate the screw 330. Rotation of the screw 330advances the screw through the retainer 338 to move the plunger 324 andblade 322 from the retracted position to the extended position.Accordingly, the blade 322 is received in the opening 320 of the housing318 and contacts the endocardial lead 100. The lead 100 is then cut byfurther extension of the blade 322 and the apparatus 10 is removed fromwithin the patient.

Referring to FIG. 8, the fourth embodiment of the apparatus 10 of thepresent invention is illustrated. The apparatus 10 includes a tubularmember 412 having a proximal end 414 and a distal end 416. The distalend 416 is generally u-shaped to define a first cutting surface 418. Atthe proximal end 414 of the tubular member 412 is a handle 420. Thetubular member 412 may be generally flexible to move within the patient.

Disposed within the tubular member 412 is a tension member 422. Thetension member 422 includes a proximal end 424 and a distal end 426. Theproximal end 424 of the tension member 422 is fixed to a lever 428. Thedistal end 426 of the tension member 422 is fixed to a blade 430. Theblade 430 is pivotally connected to the distal end 416 of the tubularmember 412 and actuation of the lever 428 about the handle 420 pivotsthe blade 430 to capture the lead 100 between the blade and the firstcutting surface 418.

Further, blade 430 has a generally s-shaped configuration and defines afirst end 432, a second end 434 and a connecting leg 436 extendingtherebetween. The first end 432 includes an inner surface that defines asecond cutting surface 438. The second end 434 is fixed to the proximalend 424 of the tension member 422. The connecting leg 436 of the blade430 is pivotally connected to the distal end 416 of the tubular member412. As illustrated the blade 430 is connected to the distal end 416 ofthe tubular member 412 generally at the midpoint of the connecting leg436. However, alternative fastening positions or techniques are easilycontemplated by one skilled in the art.

In operation, the apparatus 10 of the fourth embodiment is placed withina patient and the lead 100 is received within the u-shaped distal end416 of the tubular member 412 such that the first cutting surface 418contacts the lead 100. The lever 428 is actuated about the handle 420 todraw the tension member 422 away from the distal end 416 and pivot theblade 430 thereabout. When the blade 430 is pivoted, the second cuttingsurface 438 of the first end 432 also contacts the lead 100 to capturethe lead 100 therebetween. Further actuation of the lever 428 and thecutting surfaces 418, 438 cut through the endocardial lead 100.

Referring to a fifth embodiment of FIG. 9, the apparatus 10 includes atubular member 512 having a proximal end 514 and a distal end 516. Thedistal end 516 is generally c-shaped to define a first cutting surface518. At the proximal end 514 of the tubular member 512 is a handle 520.The tubular member 512 may be generally flexible to move within thepatient.

Disposed Within the tubular member 512 is as tension member 522. Thetension member 522 includes a proximal end 524 and a distal end 526. Theproximal end 524 of the tension member 522 is fixed to a lever 528. Thedistal end 526 of the tension member 522 is fixed to a blade 530. Theblade 530 is received within the tubular member 512 and disposed at thedistal end 516. Actuation of the lever 528 about the handle 520 linearlymoves the blade 530 to capture the lead 100 between the blade 530 andthe first cutting surface 518. The blade 530 defines a second cuttingsurface 532 and capturing the lead 100 between the blade 530 and thefirst cutting surface 518 cuts the lead 100.

In operation, the apparatus 10 of the fifth embodiment is placed withina patient and the lead 100 is received within the c-shaped distal end516 of the tubular member 512 such that the first cutting surface 518contacts the lead 100. The lever 528 is actuated about the handle 520 todraw the tension member 522 away from the distal end 516 and move theblade 530 linearly. When the blade 530 is moved, the second cuttingsurface 532 of the blade 530 also contacts the lead 100 to capture thelead 100 between the blade 530 and the first cutting surface 518.Further actuation of the lever 528 and the cutting surfaces 518, 532 cutthrough the endocardial lead 100.

Now referring to FIGS. 10-11, the sixth embodiment of apparatus 10 ofthe present invention is illustrated. The apparatus 10 includes atubular member 612 having a proximal end 614 and a distal end 616. Thedistal end 616 includes a housing 618 while the proximal end 614includes an adjustment mechanism 620. The tubular member 612 may begenerally flexible to move within the patient and optionally includereinforcements such as a braid or compressed coil to strengthen tubularmember 612 and resist compression during operation.

Disposed within the tubular member 612 is a tension member 622. Thetension member 622 includes a proximal end 624 and a distal end 626. Theproximal end 624 of the tension member 622 is fixed to the adjustmentmechanism 620 while the distal end 626 is connected to two blades 628.The adjustment mechanism 620 moves the tension member 622 and the blades628 between an extended position and a retracted position.

The adjustment mechanism 620 it a handle 630 for actuating the tensionmember 622 and blades 628 between the extended and retracted positions.Pivotally connected to the handle 630 is a lever 632 with a biasingmechanism 634, such as a spring and the like, disposed therebetween. Thebiasing mechanism 634 urges the lever 632 about the handle 630 andhence, the tension member 622 and blades 628 to one of either theextended or retracted positions. Optionally, the adjustment mechanism620 may also include a knob 636 for actuating the tension member 622 andblades 628 to a position opposite of the bias of the handle 630 andlever 632 configuration. Further, various alternatives for actuating thetension member 622 and blades 628 between positions are contemplated bythe present invention, especially techniques previously described in thepresent application.

Referring to FIGS. 11A-11C, the blades 628 of the present embodimentpivotally connected and may generally be described as have a scissorcutting action. The blades 628 are made of a generally hardened materialsuch as hardened steel, carbide and the like. The blades 628 are generalarcuate to define an inner cutting surface 638. Each blade 628 includesa first end 640 and a second end 642. The first ends 640 of the blades628 are generally rounded or blunt-tipped to minimize damage tosurrounding tissue when within a patient. The second ends 642 of theblades 628 are connected to the distal end 626 of the tension member622.

The blades 628 are received within the housing 618 disposed at thedistal end 616 of the tubular member 612. The housing 618 is preferablymade from plastic and includes tapered sides 644. The tapered sides 644urge the blades 628 to pivot about each other when moved from theextended position o the retracted position within the housing 618.

Optionally, the apparatus 10 of the sixth embodiment may also include acapture mechanism (not shown). The capture mechanism is disposed withinthe tubular member 612. The capture mechanism is preferably a wire, morepreferably a deflectable guide or snare wire, made of a flexible orbendable material and having a biased arcuate distal end (also notshown). The capture mechanism is moveable between an extended positionand a retracted position similar to the tension member 622 and theblades 628. When extended, the biased arcuate distal end wraps aroundthe endocardial lead 100, by way of example only, by snaring the lead,to draw the lead 100 close to the distal end 616 and housing 618 of thetubular member 612. When retracted, the biased arcuate distal end isgenerally longitudinal and received within the housing 618 and tubularmember 612.

In operation, the apparatus 10 of the sixth embodiment is placed withina patient. The capture mechanism is extended and the biased arcuatedistal end wraps about the endocardial lead 100. The capture mechanismis retracted to draw the lead 100 dose to the distal end 616 and housing618 of the tubular member 612. The tension member 622 and blades 628 areextended as shown in FIG. 11A. The adjustment mechanism 620 is actuatedand the tension member 622 and blades 628 are moved to the retractedposition. As seen in FIG. 11B, the blades 628 pivot, about each other atthe second end 642 to capture the lead 100 between the inner cuttingsurfaces 638 of the blades 628. Further actuation and retraction of thetension member 622 and blades 628 cuts through the lead 100 as shown inFIG. 11C. The apparatus 10 is then removed from within the patient.

While the present invention has been particularly shown and describedwith reference to the foregoing preferred and alternative embodiments,it should be understood by those skilled in the art that variousalternatives to the embodiments of the invention described herein may beemployed in practicing the invention without departing from the spiritand scope of the invention as defined in the following claims. It isintended that the following claims define the scope of the invention andthat the apparatus within the scope of these claims and theirequivalents be covered thereby. This description of the invention shouldbe understood to include all novel and non-obvious combinations ofelements described herein, and claims may be present in this or a laterapplication to any novel and non-obvious combination of these elements.The foregoing embodiments are illustrative, and no single feature orelement is essential to all possible combination that may be claimed inthis or a later application. Where the claims recite “a” or “a first”element of the equivalent thereof, such claims should be understood toinclude incorporation of one or more such elements, neither requiringnor excluding two or more such elements.

What is claimed is:
 1. An endocardial lead cutting apparatus for cuttinga lead implanted within a patient, said apparatus comprising: a flexibleshaft having a proximal end and a distal tip; a groove for relieving thelead positioned at said distal tip of said shaft, said groove beinggenerally V-shaped and defining at least one cutting surface for cuttingthe lead, wherein motion or other energy is applied through the shaft tocut the lead.
 2. The apparatus claim 1, further including a shroudpositioned about said shaft.
 3. The apparatus of claim 2, wherein saidshroud is pliable.
 4. The apparatus of claim 1, wherein said proximalend of said shaft includes a handle.
 5. The apparatus of claim 1,wherein said at least one cutting surface is comprised of a hardenedmaterial.
 6. The apparatus of claim 1, further including a lasergenerating device to cut the lead by applying radiation to the lead. 7.The apparatus of claim 6, wherein said shaft includes an optical fiberto transmit the radiation to said distal tip.
 8. The apparatus of claim1, further including an ultrasonic device to cut the lead by applyingultrasonic energy to the lead.
 9. The apparatus of claim 1, furtherincluding a vibration generating device to cut the lead by applyingvibrations to the lead. 10-13. (canceled)
 14. An endocardial leadcutting apparatus for cutting a lead implanted within a patient, saidapparatus comprising: a flexible outer tubular member having a proximalend and a distal end; a flexible inner shaft having a proximal end and adistal end, said inner shaft received within said outer tubular member;a blade positioned at said distal end of said inner shaft; a groovepositioned at said distal end of said outer tubular member for receivingthe lead; and wherein said inner shaft rotates within said outer tubularmember to cut the lead received in said positioning groove.
 15. Theapparatus of claim 14, further including a positioning mechanism to biassaid inner shaft and said outer tubular member to a home position. 16.The apparatus of claim 15, wherein said home position of said innershaft and said outer tubular member is defined by said blade beingoffset from said groove.
 17. The apparatus of claim 14, wherein saidgroove of said outer tubular member is generally V-shaped.
 18. Theapparatus of claim 14, wherein said blade of said inner shaft iscomprised of a hardened material.
 19. The apparatus of claim 14, furtherincluding a shroud positioned about said outer tubular member. 20.(canceled)
 21. The apparatus of claim 14, wherein the proximal end ofsaid outer tubular member includes a handle.
 22. The apparatus of claim14, wherein the proximal end of the inner shaft includes a handle torotate the inner shaft within the outer tubular member. 23-70.(canceled)